Method and apparatus for aiding in the detection of breast cancer

ABSTRACT

A method for detection of cancer of the breast is provided which comprises drawing a partial vacuum around the area of the breast immediately peripherally surrounding the breast nipple to restrain sphincter contraction of the duct openings in the nipple area, then, while maintaining this first mentioned partial vacuum, intermittently applying a zone of reduced pressure to the nipple itself for the extraction of secretion therefrom in sufficient quantity for the cytological examination of epithelial cells found therein for abnormalities. An apparatus is also provided for practicing the method.

United States Patent 1 [111 3,786,801 Sartorius 1*Jan. 22, 1974 [54]METHOD AND APPARATUS FOR AIDING 680,723 8/1901 Maurer 128/300 IN THEDETECTION or BREAST CANCER 2,771,072 11/1956 De Mnnlange 2,631,5833/1953 Lavergne 128/300 X [75] Inventor: Otto W. Sartorius, SantaBarbara,

Calif. A FOREIGN PATENTS OR APPLICATIONS Assignee: Diagnostic, Inc. St-PaulMinn 148,449 9/1952 Australia i28/280 Notice: The portion of theterm of this Primary Examiner Kyle L Howe" Ygg sfiigi g g ifiggAttorney, Agent, or Firm-Donald M. Sell [22] Filed: Sept. 28, 1971 [57]I ABSTRACT [21] Appl' 184501 A method for detection of cancer of thebreast is pro- Related US, A li ti D t vided which comprises drawing apartial vacuum [63] continuationdmpm of Sen No- 80163, Feb 24 around thearea of the breast immediatelyperipherally 1969, pat No. 3,608,540surrounding the breast nipple to restrain sphincter contraction of theduct openings in the nipple area, 52 us. CI. ..12s/2 F, 12s/2s2, 128/300then, While maintaining this first mentioned Partial [51] Int. Cl...-.A6lb 10/00 vacuum intermittently applying a Zone of reduced 5 Field fSearch [28/2 F 2 R 2 B, 7 280 pressure to the nipple itself for theextraction of secre- 128/231, 282 299402 304 tion therefrom insufficient quantity for the cytological examination of epithelial cellsfound therein for ab- 5 References Cited normalities. An apparatus isalso provided for practic- UNITED STATES PATENTS meflmd' 3,608,5409/1971 Sartorius 128/2 F X 2 Claims, 4 Drawing Figures METHOD ANDAPPARATUS FOR AIDING IN THE DETECTION OF BREAST CANCER This applicationis a continuation-in-part of application Ser. No. 801,613 filed Feb. 24,1969, now US. Pat. No. 3,608,540.

' INTRODUCTION The present invention relates to a method and apparatusfor aiding in the detection of breast cancer in females. Moreparticularly, this invention provides a unique application of suctionfor obtaining epithelial cells from the lining of the breast ducts andan apparatus for practicing this method.

BACKGROUND OF THE INVENTION Breast cancer ranks as the number onemalignancy in the human female and accounts for approximately onefourthof all cancers in women. Studies have shown a definite correlationbetween the size of the original cancer or lesionat-the time ofdiagnosis and the mortality rates for'cancers of the breast. The smallerthe size of the lesion, the more likely the recovery of the patient.

At the present time, early diagnosis of possible breast cancer isusually conducted by touch, and/or mammograms (breast X-rays) todetermine the presence of suspicious breast lesions. Upon detectionoflesions the differential diagnosis between benign lesions and malignantlesions in the female breast is generally confirmed by biopsy done undergeneral anesthesia in a hospital. Only about one in four lesions isfound to be malignant and the prognosis for cancer of the breast hasimproved very little over the last several decades. The diagnosticprocedure, being cumbersome, costly and time-consuming, is done onlywhen circumstances, such as discovery of an unusual lump in the breast,arouse sufficient suspicion on the part of the physician to warrant thepain and inconvenience of a biopsy to the patient.

Natural secretions from the breast are an uncommon symptom of breastcancer, and even if cancer is present may or may not contain cancercells. Thus, even though it has been known that breast cancer begins inthe lumna of the ductal system of the breast, no effective way hasheretofore been presented for obtaining satisfactory cell material fromthe lining of the ducts themselves for proper study.

THE INVENTION This invention represents a substantial improvement overthat described in my previous application in that the present inventionprovides a greatly simplified method for obtaining cells from the breastducts for examination and a correspondingly less complex apparatus forits practice. This improved method in its simplicity closely resemblesthe routine Pap" smear test procedure for the early detection of vaginalcancer.

The method described in my previous application enables the extractionof breast secretions having a sufficient quantity of epithelial cellstherein for cytological examination from a high percentage of women.However, practice of the method requires a combination of suction andirrigation of the breast with an irrigating liquid. Thus, the epithelialcells of the breast secretion are carried in the irrigating liquid,causing a consequent high degree of preparation of the extractedsecretion for cytological examination, and great care and skill in theresulting examination of the extracted secretion; the method alsorequires the use of relatively elaborate apparatus in its practice.

The present invention provides a breast secretion extraction procedureinvolving the use of a novel combination of suction pressures to thebreast to induce mammary secretions having sufficient cellular materialfor accurate diagnosis by cytoligical examination in a high percentageof women, e.g. percent or more.

The method of this invention for the early diagnosis of breast cancerrequires no irrigating liquid and thus minimizes the consequentpossibility of contamination and misinterpretation of cytologicalfindings inherent therein. This new method comprises (1) the applicationof a constant peripheral zone of reduced pressure, i.e., a suctionpressure, to the area of the breast surrounding the nipple and in veryclose proximity thereto, and (2) the intermittent application of a zoneof reduced pressure to the breast nipple itself to extract breastsecretion from the nipple while maintaining the constant suction in theperipheral zone, (3) removal of beads of breast secretion from from thenipple, and (4) cytological examination of epithelial cells dispersedtherein. Because of its innate simplicity, the absence of any foreignfluid mixed with the breast secretion, and the ease of examination ofextracted secretion, this procedure is remarkably similar in itspractice to the vaginal Pap smear test procedure.

The method of this invention enables a quick, simple and painless methodfor obtaining breast ductal secretions having a sufficientlyrepresentative quantity of ductal cells to enable reasonably accurateearly diagnosis for the presence of breast cancer. The application ofsuction to the area of the breast immediately peripherally surroundingthe nipple apparently inhibits, or restrains, any sphincter contractionotherwise present at the duct system openings into the nipple. Theintermittent suction applied to the nipple area while maintaining theperipheral area under a constant reduced pressure causes beads ofsecretion to quickly form on the nipple, which beads may be readilyremoved for examination simply by wiping the nipple with albumen coatedslides, followed by rapid fixation of the slides for cytologicalexamination under suitable magnification. To cleanse the nipple andsoften inspissated material which may be present at the mouths of theduct openings into the nipple before practicing the method, theapplication of a hot towel to the breast nipple and subsequent sterilecleansing of the nipple by the use of alcohol, Zephiran, 2% acetic acidor acetone is recommended.

The device or apparatus I have invented for practicing my new methodcomprises a cup having a continuous outer sidewall and a continuousinner sidewall spaced therefrom defining a continuous peripheral recessand a central recess, both opening into the mouth of the cup and beingotherwise sealingly separated from one another. The cup is adapted sothat as it is pressed against the breast the peripheral recess closelysurrounds the nipple area of the breast and the central recess receivesthe nipple therein. The cup has a pair of openings in the bottom thereoffor creating suction in the recesses. One of the openings communicateswith the peripheral recess to seal the cup against the breast and theother communicates with the central recess to withdraw breast secretionfrom the nipple of the breast received therewithin.

The practice of the method and the construction of the presentlypreferred form of apparatus for practicing the method are described inmore detail with reference to the accompanying drawing wherein:

FIG. 1 is a perspective view of a form of apparatus for the practice ofthe invention;

FIG. 2 is a cross-sectional view of the device of FIG. 1 takensubstantially along section line 2-2;

FIG. 3 is a bottom view of the device of FIG. 1; and

FIG. 4 is a side view of the device of FIG. 1 in its functional positionon the breast.

Referring first to FIG. 1, a form of device or apparatus for practicingthe method of this invention is illustrated, being designated in itsentirety by the numeral 100. This device comprises a cup having acontinuous outer cylindrical sidewall 102 and a continuous innercylindrical sidewall 104 concentrically spaced therefrom. The sidewallsrise from a flat, circular bottom wall 106 and divide the cup 100 intoouter and inner recesses 108 and 110, respectively. The device can be ofany suitable non-porous material but is preferably of a tough, rigid,transparent plastic inert to body fluids, such as polypropylene orpolymethyl methacrylate, or other suitable tough synthetic plasticpolymer. Ports 112 and 114 open through the bottom wall 106 of the cuprespectively into outer and inner recesses 108 and 110. Tubular nipples116 and 118, depending from the bottom 106 of the breast cup 100,provide means for the attachment of the mouth of a syringe thereto forevacuation of the recesses. As these devices are inexpensive enough tobe discarded after use, any suitable port guide arrangement can be used,e.g., each port may simply be sealed with a rubbery sealing membranewhich is puncturable by a hollow syringe needle.

After inspissated material at the mouth of the nipple has been loosened,where necessary, and the nipple and nipple area have been cleaned asnoted hereinbefore, the device is applied to the breast 126. Rims 120and 122, respectively, of the outer and inner sidewalls of the cup 100seat firmly against the flesh of the breast surrounding the nipple, theouter or peripheral recess 108 closely surrounding, but excluding, thenipple 128 of the breast and the inner or central recess 110 snuglyreceived the nipple 128 therewithin. Following placement of the device,evacuation of the outer recess 108 is carried out. This may beaccomplished by application of a conventional 10 c.c. syringe 124 toport extension 118 and withdrawal of the syringe plunger to the 5 or 6c.c. mark whereupon clamp 132 may be tightened on the flexible tubing130 interconnecting the syringe tip and the port extension to maintain aconstant partial vacuum in the outer recess of the cup. Upon creation ofreduced pressure by this means in the outer recess, the device isself-retained against the breast and sphincter contraction at the end ofthe duct system opening into the nipple is restrained. The extraction orwithdrawal of breast secretion may begin.

To extract the breast secretion, the inner recess of the cup withinwhich the nipple of the breast snugly rests is subjected to anintermittent partial suction, i.e. reduced pressure or partial vacuum,as through use of a 10 c.c. syringe applied to port extension 116 bymeans of another piece of flexible interconnecting tubing and thesyringe plunger alternately withdrawn to the 5 or 6 c.c. mark and thenpressed forward to first subject the nipple to suction pressure and thenrelease the nipple from suction pressure and thus milk breast secretionfrom the nipple. The secretion thus obtained forms as beads on thenipple and may then be subjected to examination by known techniques forthe pathological examination of cellular material contained therein,e.g. by serial smearing on albumen coated slides followed by fixationfor microscopic examination, or other cytological examination procedure.

While the invention has been described with reference to humanmammography and the early detection of cancer, the invention isapplicable to the examination of any mammal and to the detection ofother cellular disturbances in the breast ductal system.

That which is claimed is:

1. A method for withdrawing breast secretion for the detection ofcellular abnormality within the breast of a mammalian female comprising(1) contacting the breast with a cup having a bottom and outer and innercontinuous sidewalls spaced from one another dividing the cup intoperipheral and central recesses opening into the mouth of the cup, themouth of the cup being pressed against the breast with the nipple of thebreast being received in the central recess and the portion of thebreast immediately surrounding the nipple being contacted by the edgesof said sidewalls and closing the mouth of the cup, (2) reducing thepressure in the peripheral recess of the cup to thereby firmly seat andhold the cup against the breast and, (3) while maintaining the reducedpressure in said peripheral recess intermittently reducing the pressurein the central recess to cause natural secretion from the breast to beadon said nipple, then (4) releasing the cup from the breast and removingsaid beads of natural secretion to enable examination of cells containedtherewithin for detection of breast abnormalities.

2. A device adapted for self-retention on the breast of a mammalianfemale to facilitate the withdrawal of natural secretions therefrom,said device comprising a cup being generally circular in cross sectionand having a closed bottom with continuous concentrically spaced outerand inner sidewalls rising therefrom with the upper edges thereofterminated at and forming the mouth of the cup, said concentricallyspaced sidewalls dividing said cup into a peripheral recess and acentral recess opening into the mouth of the cup, said inner sidewallsealingly separating said central recess and said peripheral recess fromone another, said central recess being of a size to snugly receive thenipple of a breast therewithin and said peripheral recess presenting aring-shaped opening of a size to closely surround the portion of thebreast immediately surrounding the nipple area, said cup having a pairof port means therein opening independently into each of said recesses,each of said port means including means for the attachment of suctionmeans thereto so that when the device is placed in position against thebreast with the nipple of the breast seated in said central recess therecesses of the cup may be individually depressurized.

1. A method for withdrawing breast secretion for the detection ofcellular abnormality within the breast of a mammalian female comprising(1) contacting the breast with a cup having a bottom and outer and innercontinuous sidewalls spaced from one another dividing the cup intoperipheral and central recesses opening into the mouth of the cup, themouth of the cup being pressed against the breast with the nipple of thebreast being received in the central recess and the portion of thebreast immediately surrounding the nipple being contacted by the edgesof said sidewalls and closing the mouth of the cup, (2) reducing thepressure in the peripheral recess of the cup to thereby firmly seat andhold the cup against the breast and, (3) while maintaining the reducedpressure in said peripheral recess intermittently reducing the pressurein the central recess to cause natural secretion from the breast to beadon said nipple, then (4) releasing the cup from the breast and removingsaid beads of natural secretion to enable examination of cells containedtherewithin for detection of breast abnormalities.
 2. A device adaptedfor self-retention on the breast of a mammalian female to facilitate thewithdrawal of natural secretions therefrom, said device comprising a cupbeing generally circular in cross section and having a closed bottomwith continuous concentrically spaced outer and inner sidewalls risingtherefrom with the upper edges thereof terminated at and forming themouth of the cup, said concentrically spaced sidewalls dividing said cupinto a peripheral recess and a central recess opening into the mouth ofthe cup, said inner sidewall sealingly separating said central recessand said peripheral recess from one another, said central recess beingof a size to snugly receive the nipple of a breast therewithin and saidperipheral recess presenting a ring-shaped opening of a size to closelysurround the portion of the breast immediately surrounding the nipplearea, said cup having a pair of port means therein opening independentlyinto each of said recesses, each of said port means including means forthe attachment of suction means thereto so that when the device isplaced in position against the breast with the nipple of the breastseated in said central recess the recesses of the cup may beindividually depressurized.